DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive
care pharmaceutical company dedicated to providing health care
professionals a synergistic portfolio of medicines to help cancer
patients adhere to their therapy and manage side effects arising
from their cancer treatment, today announced the launch of a
smartphone app to provide cancer patients an educational resource
to help improve oral care and management of oral mucositis. This is
being accompanied by the release of a list of “Top 10 Oral Care
Tips” < http://gelclair.com/top-10-oral-hygiene-tips
> for Cancer Patients.
Gelclair® is an FDA-approved bioadherent
oral rinse gel for treating the pain that accompanies oral
mucositis (OM). (Photo: Business Wire)
(Editor’s note: Top 10 Oral Hygiene Tips video
file and individual photos are available for
download and web use.)
The Oral Mucositis Care app, available for iPhone and Android
devices, provides educational resources and tips for patients about
managing oral mucositis, a common and often intensely painful side
effect occurring in cancer patients who undergo radiation and
chemotherapy. The app offers patients helpful tips, a reference
guide to good oral hygiene and ways to help manage the pain and
discomfort of oral mucositis.
“Oral mucositis causes significant discomfort and pain in many
patients, and may delay or interrupt cancer treatment,” said David
J. Drutz, M.D., DARA BioSciences' Chief Executive Officer and Chief
Medical Officer. “We designed this application to be a resource for
patients and their care givers to help them manage and hopefully
improve symptoms of oral mucositis.”
It is estimated there are more than 50,000 Americans diagnosed
with head and neck cancer each year, and research shows that up to
100 percent of patients who receive radiotherapy for head and neck
cancers develop oral mucositis. Additionally, oral mucositis
develops in 30 to 75 percent of patients who receive chemotherapy
for any kind of cancer. Oral mucositis is diagnosed in
approximately 400,000 patients in the United States each year.
“The painful symptoms of oral mucositis, which often limit a
patient’s ability to eat, drink and talk comfortably, have the
potential to derail a prescribed course of radiation or
chemotherapy,” said Elizabeth Feldman, DMD, MS, a maxillofacial
prosthodontist and dental oncologist at UF Health Cancer
Center-Orlando Health. “Educating patients about proper oral
hygiene techniques and treatment options for painful oral mucositis
symptoms is vitally important to improve their care and
wellbeing.”
Dr. Feldman consulted with DARA in the development of the oral
mucositis patient app.
According to the Oral Cancer Foundation (OCF), a non-profit
organization that provides information, patient support,
sponsorship of research and advocacy related to oral cancers, oral
mucositis is considered the “most common, debilitating
complication” of cancer treatments. “That’s especially true of
chemotherapy and radiation,” said Brian Hill, a stage 4 oral cancer
survivor and founder and executive director of the OCF. “In
addition to severe pain and nutritional problems as a result of the
inability to eat, the severe open sores in the mucosa can increase
the risk of infection.”
The release of Oral Mucositis Care follows the 15th annual
recognition of April as Oral Cancer Awareness month, a national
effort encouraging dental practices to offer free oral cancer
screenings to people in their communities to help catch oral cancer
in its earliest and most treatable stage. Organizations such as the
Academy of General Dentistry (AGD), the American Academy of Oral
and Maxillofacial Pathology (AAOMP), the American Academy of Oral
Medicine (AAOM), the American Academy of Periodontology (AAP), the
American Association of Oral and Maxillofactial Surgeons (AAOMS),
the American Dental Association (ADA), and the American Dental
Hygienists’’ Association (ADHA) have all joined OCF in supporting
this important campaign.
DARA BioSciences last year reintroduced Gelclair®, an
FDA-approved bioadherent oral rinse gel for treating the pain that
accompanies oral mucositis (OM). Gelclair is the most
clinically studied and published of all oral gel devices approved
for oral mucositis in the United States. In clinical trials,
Gelclair has been demonstrated to rapidly and effectively relieve
pain. To download the app, visit the iTunes Store or Google Play
and search for “Oral Mucositis Care.” The app will also be
available on www.Gelclair.com. For optimal performance, the latest
software versions are recommended.
About Oral Mucositis
Oral Mucositis (OM) is an acute inflammation and ulceration of
the surface of the mouth and throat in cancer patients caused by
chemotherapy and radiation treatment, which disrupt rapidly
dividing epithelial progenitor cells. It is estimated that
approximately 400,000 cases of OM are diagnosed annually. OM can be
an intensely painful condition that often leads to difficulties
swallowing food and fluids, potentially leading to dehydration and
malnutrition. OM can also lead to delays in cancer treatments,
through chemotherapy dose reductions, breaks in radiation
treatment, cessation of cancer therapy, hospitalization and
reliance on parenteral nutrition. OM is seen most often in patients
receiving radiation therapy for head and neck cancer, and in
patients receiving high-dose chemotherapy conditioning prior to
hematopoietic stem cell transplantation. However, any patient
receiving cancer treatment is at risk.
About Gelclair® (Bioadherent
oral rinse gel)
Gelclair® is an easy-to-use bioadherent oral rinse gel indicated
for the management and relief of pain of various etiologies,
including oral mucositis/stomatitis, irritation due to oral
surgery, ulcers caused by braces or ill-fitting dentures, certain
systemic diseases, and for diffuse aphthous ulcers. Gelclair® has a
unique hyaluronic acid – based formulation and does not contain
alcohol, thereby reducing the risk of painful burning and drying.
Gelclair® has been broadly studied, demonstrating rapid and
effective relief of pain, improvement in patients’ ability to eat
and drink and reducing the need for rescue analgesics. DARA has
exclusive U.S. commercial rights to Gelclair® through a license
with The Helsinn Group in Switzerland.
Gelclair® Important Safety Information
Do not use Gelclair® if there is a known or suspected
hypersensitivity to any of its ingredients. No adverse effects have
been reported in clinical trials, although post marketing reports
have included infrequent complaints of burning sensation in the
mouth. Do not eat or drink for at least 30-60 minutes following
treatment. If Gelclair® is swallowed accidently, no adverse effects
are anticipated.
For additional information, including a copy of the Full
Prescribing Information, please visit our web site at
www.gelclair.com
About DARA BioSciences,
Inc.
DARA BioSciences, Inc. of Raleigh, North Carolina, is an
oncology supportive care specialty pharmaceutical company dedicated
to providing healthcare professionals a synergistic portfolio of
medicines to help patients with cancer adhere to their therapy and
manage side effects arising from their cancer treatments.
In addition to Gelclair®, DARA holds exclusive U.S. marketing
rights to Soltamox® (tamoxifen citrate) oral solution, the only
liquid form of tamoxifen, indicated for the treatment of metastatic
breast cancer, the adjuvant treatment of breast cancer, the
reduction of risk of invasive breast cancer in women with ductal
carcinoma in situ, and to reduce breast cancer incidence in women
at high risk for breast cancer. Soltamox® offers an option to
patients who prefer or need a liquid form of tamoxifen. DARA
licensed the U.S. rights to Soltamox® from UK-based Rosemont
Pharmaceuticals, Ltd.
Under an agreement with Innocutis, DARA also markets Bionect®
(hyaluronic acid sodium salt, 0.2%) a topical treatment for skin
irritation and burns associated with radiation therapy, in U.S.
oncology/radiology markets. Bionect® is indicated for the dressing
and management of partial to full thickness dermal ulcers (pressure
sores, venous stasis ulcers, arterial ulcers, diabetic ulcers),
wounds including cuts, abrasions, donor sites, and post-operative
incisions, irritation of the skin, and first and second degree
burns.
DARA is focused on expanding its portfolio of oncology
supportive care products in the United States, via in-licensing
and/or partnering of complementary late-stage and approved
products. In addition, the company wishes to identify a strategic
partner for the clinical development of KRN5500, currently in Phase
2 for the treatment of chronic, treatment refractory,
chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has
granted KRN5500 orphan drug status for the treatment of CCIPN and
designated it as a Fast Track Drug.
In January 2014, DARA kicked off its new partnership with Alamo
Pharma Services, a subsidiary of Mission Pharmacal, in deploying a
dedicated 20-person national sales team in the U.S. oncology
market. In addition to promoting DARA's products Soltamox®
(tamoxifen citrate oral solution), Gelclair® and Bionect®, this
specialized oncology supportive care sales team also will provide
clinicians with access to three Mission Pharmacal products:
Ferralet® 90 (for iron deficiency anemia), BINOSTO® (alendronate
sodium effervescent tablet indicated for the treatment of
osteoporosis), and Aquoral® (for chemotherapy/radiation
therapy-induced dry mouth).
Important Safety Information and full Prescribing Information
for Mission Pharmacal’s products may be found at: www.Ferralet.com,
www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at
www.darabio.com.
Tamoxifen Important Safety
Information
Tamoxifen citrate is contraindicated in women who require
concomitant coumadin-type anticoagulant therapy, in women with a
history of deep vein thrombosis or pulmonary embolus, and in women
with known hypersensitivity to the drug or any of its
ingredients.
Serious and life-threatening events associated with tamoxifen in
the risk reduction setting (women at high risk for cancer and women
with DCIS) include uterine malignancies, stroke and pulmonary
embolism.
The most common adverse reactions to tamoxifen treatment are
(incidence ≥ 20%) hot flashes, fluid retention, vaginal discharge,
vaginal bleeding, vasodilatation, nausea, irregular menses, weight
loss, and musculoskeletal events.
Tamoxifen carries the following Boxed Warning:
****************************************************************************************************************
WARNING – For Women with Ductal Carcinoma in Situ (DCIS) and
Women at High Risk for Breast Cancer: Serious and
life-threatening events associated with tamoxifen in the risk
reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism.
Incidence rates for these events were estimated from the NSABP P-1
trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in
Breast Cancer Incidence In High Risk Women). Uterine
malignancies consist of both endometrial adenocarcinoma (incidence
rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for
placebo) and uterine sarcoma (incidence rate per 1,000 women-years
of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for tamoxifen vs.
1.00 for placebo**. For pulmonary embolism, the incidence rate per
1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies
were fatal. Health care providers should discuss the potential
benefits versus the potential risks of these serious events with
women at high risk of breast cancer and women with DCIS considering
tamoxifen to reduce their risk of developing breast cancer. The
benefits of tamoxifen outweigh its risks in women already diagnosed
with breast cancer.
*Updated long-term follow-up data (median length of follow-up is
6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the
Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing
Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical
Studies in Prescribing Information.
***********************************************************************************************************
The full Prescribing Information for Soltamox is available at
www.soltamox.com/prescribing-information.
Bionect® Important Safety Information
Do not administer Bionect® to patients with known
hypersensitivity to any of the ingredients in this product. Do not
use concomitantly with disinfectants containing quaternary ammonium
salts. Each tube of Bionect® should be used by only one person to
reduce the risk of cross infection. Prolonged use may give rise to
sensitization.
The full prescribing information for Bionect® is available at
www.bionect.com.
Safe Harbor Statement
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities
Exchange Act of 1934, as amended, and are subject to risks and
uncertainties. These statements are based on the current
expectations, estimates, forecasts and projections regarding
management’s beliefs and assumptions. In some cases, you can
identify forward looking statements by terminology such as “may,”
“will,” “should,” “hope,” “expects,” “intends,” “plans,”
“anticipates,” “contemplates,” “believes,” “estimates,” “predicts,”
“projects,” “potential,” “continue,” and other similar terminology
or the negatives of those terms. Such forward-looking statements
are subject to factors that could cause actual results to differ
materially for DARA from those projected. Important factors that
could cause actual results to differ materially from the
expectations described in these forward-looking statements are set
forth under the caption "Risk Factors" in DARA's most recent Annual
Report on Form 10-K, filed with the SEC on February 4, 2014, and
DARA's other filings with the SEC from time to time. Those factors
include risks and uncertainties relating to DARA's current cash
position and its need to raise additional capital in order to be
able to continue to fund its operations; the stockholder dilution
that may result from capital raising efforts and the exercise or
conversion, as applicable, of DARA's outstanding options, warrants
and convertible preferred stock; full-ratchet anti-dilution
protection afforded investors in prior financing transactions that
may restrict or prohibit DARA's ability to raise capital on terms
favorable to the Company and its current stockholders; DARA's
limited operating history which may make it difficult to evaluate
DARA's business and future viability; DARA's ability to timely
commercialize and generate revenues or profits from Soltamox,
Soltamox, Bionect or other products given that DARA only recently
hired its initial sales force and DARA's lack of history as a
revenue-generating company; DARA's ability to achieve the desired
results from the agreements with Mission and Alamo; FDA and other
regulatory risks relating to DARA's ability to market Soltamox,
Soltamox, Bionect or other products in the United States or
elsewhere; DARA's ability to in-license and/or partner products;
the current regulatory environment in which DARA sells its
products; the market acceptance of those products; dependence on
partners and third-party manufacturers; successful performance
under collaborative and other commercial agreements; DARA's ability
to retain its managerial personnel and to attract additional
personnel; potential product liability risks that could exceed
DARA's liability coverage; potential risks related to healthcare
fraud and abuse laws; competition; the strength of DARA's
intellectual property, the intellectual property of others and any
asserted claims of infringement, and other risk factors identified
in the documents DARA has filed, or will file, with the Securities
and Exchange Commission ("SEC"). Copies of DARA's filings with the
SEC may be obtained from the SEC Internet site at
http://www.sec.gov. DARA expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in DARA's expectations with regard thereto or any change in events,
conditions, or circumstances on which any such statements are
based. DARA BioSciences and the DARA logo are trademarks of DARA
BioSciences, Inc.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140603005536/en/
Media Contact:
David Connolly
LaVoie Group
617-374-8800, Ext. 108
dconnolly@lavoiehealthscience.com
Katie Dagenais M.A.
Orlando Health
UF Health Cancer Center
407-242-0305
katie.dagenais@orlandohealth.com
Investor Contact:
Jim Polson
FTI Consulting
312-553-6730
jim.polson@fticonsulting.com
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